Ovarian Reserve in Premenopausal Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2020-07-13

Brief Summary

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This is a translational, mutlicentre study. The aim of this study is to determine whether pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.

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Detailed Description

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It is proposed that levels of AMH and inhibin A and B measured will give an indication of the residual ovarian reserve in women with breast cancer treated with chemotherapy. In addition, AMH might give an indication of the possible efficacy of GNRH agonists in fertility preservation and the effect on ovarian follicular reserve using different adjuvant chemotherapy regimens. Those likely to be offered GNRH agonists are younger women with no children and a wish to have some in the future. Older women who have completed their families are less likely to be offered a GNRH agonist.

Conditions

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Premenopausal Breast Cancer Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Documented histological diagnosis of invasive breast cancer
2. Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)\*
3. Female patients aged between 18 and 50 years
4. Premenopausal status as defined by a hormone profile within the pre-menopausal range as defined by local lab

OR The patient's last menstrual period had to be within the last 180 days

OR An IUD is used for contraception.
5. Ability to provide written informed consent

* Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible